Safety evaluation studies of calcium EDTA

Oser, Bernard L.; Oser, Mona; Spencer, Howard C.

doi:10.1016/0041-008x(63)90039-5

Cited by 24 publications

(20 citation statements)

References 2 publications

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“…This ADI for EDTA of 1.9 mg/kg bw per day, established by JECFA from the ADI for calcium disodium EDTA (E 385) based on the study of Oser et al (1963) (JECFA, 2007), was used by the ANS Panel in 2010.…”

Section: Discussionmentioning

confidence: 99%

“…In its previous opinion (EFSA ANS Panel, 2010), the Panel noted that no chronic toxicity or carcinogenicity studies had been conducted with ferric sodium EDTA; however, several studies were presented that had been conducted with other EDTA salts such as trisodium EDTA (NCI, 1977), calcium disodium EDTA (Oser et al, 1963) and disodium EDTA (Yang, 1964). From these studies, the Panel concluded that EDTA salts do not raise concern with respect to carcinogenicity.…”

Section: Studies On Other Edta Saltsmentioning

confidence: 99%

“…Based on the new information provided in the dossier, the Panel noted that also calcium disodium EDTA was of low acute toxicity as the oral LD50 was reported to be 10,000 mg/kg bw in the rat (strain and species not specified), 7,000 mg/kg bw in the rabbit (strain and species not specified) and 12,000 mg/kg bw in the dog (Oser et al, 1963).…”

Section: Studies On Other Edta Saltsmentioning

confidence: 99%

“…In its 2010 assessment, the Panel considered one dietary multigenerational study with calcium disodium EDTA (Oser et al, 1963), and noted that no compound-related mortality, reproductive, or teratogenic effects were reported. At the time, the Panel identified a NOAEL of 195 mg EDTA/kg bw per day (EFSA ANS Panel, 2010).…”

Section: Reproduction and Developmental Toxicitymentioning

confidence: 99%

“…In a 12-month study, 16 mongrel dogs (6 months of age, 2 males and 2 females in the control and 1 male and 3 females in each of the test groups) received either a control diet (30 g ration/kg bw per day) or the control diet supplemented with 50, 100 or 250 mg calcium disodium EDTA/kg bw per day (equal to 58, 130 and 338 mg/kg bw per day) (Oser et al, 1963). No statistically significant differences were reported in body weight, clinical pathology parameters or organ weights between the calcium disodium EDTA-treated groups and controls.…”

Section: Studies On Other Edta Saltsmentioning

confidence: 99%

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Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control

Younes¹,

Aggett²,

Aguilar³

et al. 2018

EFS2

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The present opinion deals with the evaluation of the proposed increase of the currently authorised maximum amounts of ferric sodium ethylenediaminetetraacetic acid (EDTA) as a novel food ingredient used as a source of iron, and its extension of use in processed cereal-based foods and baby foods. The applicant also provided information on two forms of ferric sodium EDTA, one previously assessed by EFSA and a new one of finer consistency. To support the proposed changes to the uses of ferric sodium EDTA, the applicant proposed a revision of the current acceptable daily intake (ADI) for EDTA, derived from that set for the food additive calcium disodium EDTA (E 385). The Panel confirmed that ferric sodium EDTA is a source from which iron is bioavailable. In assessing the safety of the proposed revision to the existing specifications for the novel food ingredient ferric sodium EDTA, the Panel noted that this would not discriminate between the previously evaluated substance and the one of finer consistency. In particular, the Panel noted that particle size was not one of the proposed parameters for the revised specifications. The Panel noted that it was not possible to determine whether particles of ferric sodium EDTA in the nano range were present in the product with finer consistency in the solid form. The toxicological data submitted did not add any new relevant information to the database on which the current ADI for EDTA is based. Consequently, the Panel concluded that there was no sound scientific justification to increase the ADI for EDTA and hence increase the use levels of ferric sodium EDTA or introduce additional uses as proposed by the applicant. The Panel recommended that additional toxicological data should be provided to address the shortcomings in the available toxicity database prior to the re-evaluation of calcium disodium EDTA (E 385). Acknowledgements: The Panel wishes to thank the members of the Working Group on Applications for the preparatory work on this scientific output, and EFSA staff members Fabiola Pizzo, Ana Maria Rincon and Camilla Smeraldi for the support provided to this scientific output.

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Section: Discussionmentioning

confidence: 99%

Section: Studies On Other Edta Saltsmentioning

confidence: 99%

Section: Studies On Other Edta Saltsmentioning

confidence: 99%

Section: Reproduction and Developmental Toxicitymentioning

confidence: 99%

Section: Studies On Other Edta Saltsmentioning

confidence: 99%

See 3 more Smart Citations

Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control

Younes¹,

Aggett²,

Aguilar³

et al. 2018

EFS2

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Calcium Disodium Ethylenediamine‐Tetraacetate 62‐33‐9

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Sax's Dangerous Properties of Industrial Materials

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Ethylendiamintetraessigsäure (EDTA) und ihre Alkalisalze [MAK Value Documentation in German language, 2009]

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The MAK‐Collection for Occupational Health and Safety

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Veröffentlicht in der Reihe Gesundheitsschädliche Arbeitsstoffe , 46. Lieferung, Ausgabe 2009 Der Artikel enthält folgende Kapitel: Allgemeiner Wirkungscharakter Wirkungsmechanismus Toxikokinetik und Metabolismus Erfahrungen beim Menschen Einmalige Exposition Wiederholte Exposition Wirkung auf Haut und Schleimhäute Allergene Wirkung Reproduktionstoxizität Genotoxizität Kanzerogenität Tierexperimentelle Befunde und In‐vitro‐Untersuchungen Akute Toxizität Subakute, subchronische und chronische Toxizität Wirkung auf Haut und Schleimhäute Allergene Wirkung Reproduktionstoxizität Genotoxizität Kanzerogenität Bewertung

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Safety evaluation studies of calcium EDTA

Cited by 24 publications

References 2 publications

Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control

Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control

Calcium Disodium Ethylenediamine‐Tetraacetate 62‐33‐9

Ethylendiamintetraessigsäure (EDTA) und ihre Alkalisalze [MAK Value Documentation in German language, 2009]

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